Application 020041

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMINOSYN II 15% IN PLASTIC CONTAINER	AMINO ACIDS	INJECTABLE;INJECTION	15% (15GM/100ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	AMINO ACIDS	15% (15GM/100ML)	INJECTABLE / INJECTION			1991-12-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020041-001	AMINOSYN II 15% IN PLASTIC CONTAINER	15% (15GM/100ML)	INJECTABLE / INJECTION	1991-12-19	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINE	ICU Medical Inc.	5b426208-f090-4650-86c3-89040ba45c2d	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020041 application number: NDA020041 ndc (product): 0990-7171

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	Hospira, Inc.	NDA	Current
0409-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	Hospira, Inc.	NDA	Current
0409-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	Hospira, Inc.	NDA	Current
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	ICU Medical Inc.	NDA	Current
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	ICU Medical Inc.	NDA	Current
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	ICU Medical Inc.	NDA	Current
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	ICU Medical Inc.	NDA	Current
0990-7171	Aminosyn II	ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, and GLYCINE	ICU Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21075	SUPPL	2004-05-27
21074	SUPPL	2002-08-21